# DEN200066: BioFire Joint Infection (JI) Panel

- Pathway: De Novo (Direct)
- Applicant: Biofire Diagnostics, LLC
- Decided: Apr 29, 2022 after 549 days
- Product code: QSN (Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System)
- Device class: 2
- Regulation: 21 CFR 866.3988
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
The BioFire Joint Infection (JI) Panel is a multiplexed nucleic-acid-based, in vitro diagnostic test intended for use with BioFire FilmArray 2.0 and BioFire FilmArray Torch Systems for the simultaneous qualitative detection and identification of multiple bacterial and yeast nucleic acids and select antimicrobial resistance genes from synovial fluid obtained from individuals suspected to have a joint infection. The following organisms are identified using the BioFire JI Panel: Anaerococcus prevotii/vaginalis, Bacteroides fragilis, Candida spp., Candida albicans, Citrobacter, Clostridium perfringens, Cutibacterium avidum/granulosum, Enterobacter cloacae complex, Enterococcus faecalis, Enterococcus faecium, Escherichia coli, Fingoldia magna, Haemophilus influenzae, Kingella kingae, Klebsiella aerogenes, Klebsiella pneumoniae group, Morganella morganii, Neisseria gonorrhoeae, Parvimonas micra, Peptoniphilus, Peptostreptococcus anaerobius, Proteus spp., Pseudomonas aeruginosa, Salmonella spp., Serratia marcescens, Staphylococcus aureus, Staphylococcus lugdunensis, Streptococcus spp., Streptococcus agalactiae, Streptococcus pneumoniae, and Streptococcus pyogenes. The BioFire JI Panel contains assays for the detection of genetic determinants associated with S. aureus resistance to methicillin (mecA/C) in conjunction with the SCCmec right extremity junction (MREJ)), enterococcal resistance to vancomycin (vanA and vanB), and some mechanisms of gram-negative bacterial resistance ß-lactams including penicillins, cephalosporins, monobactams, and carbapenems (blaCTX-M, blaIMP, blaKPC, blaNDM, blaOXA-48-like, blaVIM). Detection of these genetic determinants can aid in the identification of potentially antimicrobial-resistant organisms in synovial fluid samples. The antimicrobial resistance gene or marker detected may or may not be associated with the agent responsible for disease. Negative results for these select antimicrobial resistance gene assays do not indicate susceptibility, as multiple mechanisms of resistance to methicillin, vancomycin, and ß-lactams exist. The BioFire JI Panel is indicated as an aid in the diagnosis of specific agents of joint infection and results should be used in conjunction with other clinical and laboratory findings. Negative results may be due to infection with pathogens that are not detected by this test, pathogens present below the limit of detection of the assay, or infection that may not be detected in a synovial fluid specimen. Positive results do not rule out co-infection with other organisms. The BioFire JI Panel is not intended to monitor treatment for joint infections. Culture of synovial fluid is necessary to recover organisms for susceptibility testing and epidemiological typing, to identify organisms in the synovial fluid that are not detected by the BioFire JI Panel, and to further identify species in the genus, complex or group results.

Source page: https://510kreport.com/device/DEN200066
Methodology: https://510kreport.com/methodology